McNeil Consumer Healthcare Is Voluntarily Withdrawing Infants’ Cough And Cold Products: Concentrated Tylenol® Infant’s Drops Plus Cold, Concentrated Tylenol® Infant’s Drops Plus Cold And Cough And Pediacare® Infant Drops Products

McNeil Consumer Healthcare, a division of McNeil-PPC, Inc., announced today that the company is voluntarily withdrawing certain infants’ cough and cold products from the market. When used as directed, these medicines are generally recognized as safe and effective. While most parents use these medicines appropriately and follow dosing directions, an assessment of available data on the use of pediatric cough and cold medicines has identified rare instances of misuse leading to overdose, particularly in infants under two years of age.

McNeil Consumer Healthcare is withdrawing CONCENTRATED INFANTS’ TYLENOL® DROPS PLUS COLD; CONCENTRATED INFANTS’ TYLENOL® DROPS PLUS COLD & COUGH; PEDIACARE® INFANT DROPS DECONGESTANT (PSE); PEDIACARE® INFANT DROPS DECONGESTANT & COUGH (PSE); PEDIACARE® INFANT DROPPER DECONGESTANT (PE); PEDIACARE® INFANT DROPPER LONG-ACTING COUGH; and PEDIACARE® INFANT DROPPER DECONGESTANT & COUGH (PE) products from the U.S. market.

Cough and cold products for children age two and over and single-ingredient pain reliever/fever reducers expressly labeled for infantsare not included in this voluntary withdrawal and remain available for parents and caregivers.

“This voluntary action by McNeil Consumer Healthcare is based on the company’s long-standing commitment to the appropriate use of medications by parents and physicians,” said Ashley McEvoy, President, McNeil Consumer Healthcare. “McNeil Consumer Healthcare is committed to providing parents with safe and effective over-the-counter medications that treat their child’s cough and cold symptoms. In addition to taking this voluntary action, McNeil Consumer Healthcare, along with our industry partners, supports the Consumer Healthcare Products Association recommendations that were recently submitted to the U.S. Food and Drug Administration (FDA). These recommendations include label changes to OTC cough and cold medicines advising ’do not use’ in children under two years of age. Our voluntary action in removing CONCENTRATED INFANTS’ TYLENOL® DROPS PLUS COLD; CONCENTRATED INFANTS’ TYLENOL® DROPS PLUS COLD & COUGH; and PEDIACARE® INFANT DROPS products from the market is consistent with these recommendations.”

The recommendations that were submitted by the Consumer Healthcare Products Association are intended to help reduce misuse leading to overdose by further promoting the appropriate use of OTC cough and cold medicines in children for relief of their symptoms and by further encouraging communication between parents and their doctors. In addition to the label change recommendations for OTC cough and cold medicines, the submission also reinforces the industry’s continued commitment to working with the FDA and pediatric experts to ensure that parents and doctors have appropriate treatment choices for their children through ongoing educational and scientific efforts.

Consumers or retailers who have questions or concerns about the products described in this communication should contact McNeil’s Consumer Relationship Center at 1-877-895-3665 (English) or 1-888-466-8746 (Spanish) or visit www.tylenol.com.